Product Information
Registration Status: ActiveAPO-AZITHROMYCIN TABLET 250MG is approved to be sold in Singapore with effective from 2011-07-29. It is marketed by PHARMAFORTE SINGAPORE PTE LTD, with the registration number of SIN13991P.
This product contains Azithromycin 250mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Apotex Inc. in CANADA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Azithromycin is a semi-synthetic macrolide antibiotic of the azalide class. Like other macrolide antibiotics, azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of the bacterial 70S ribosome. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the process of translation. Its effects may be bacteriostatic or bactericidal depending of the organism and the drug concentration. Its long half life, which enables once daily dosing and shorter administration durations, is a property distinct from other macrolides.
Indication
For the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions: H. influenzae, M. catarrhalis, S. pneumoniae, C. pneumoniae, M. pneumoniae, S. pyogenes, S. aureus, S. agal
Mechanism of Action
Azithromycin binds to the 50S subunit of the 70S bacterial ribosomes, and therefore inhibits RNA-dependent protein synthesis in bacterial cells.
Pharmacokinetics
- Absorption
- Bioavailability is 37% following oral administration. Absorption is not affected by food. Azithromycin is extensively distributed in tissues with tissue concentrations reaching up to 50 times greater than plasma concentrations. Drug becomes concentrated within macrophages and polymorphonucleocytes giving it good activity against Chlamydia trachomatis.
- Distribution
- * 31.1 L/kg
- Metabolism
- Hepatic. In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed.
- Elimination
Clearance
* apparent plasma cl=630 mL/min [following single 500 mg oral and i.v. doses]
Toxicity
Potentially serious side effects of angioedema and cholestatic jaundice were reported
Active Ingredient/Synonyms
Azithromycine | Azithromycinum | Azitromicina | Azithromycin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.